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Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Chronic pain, osteoarthritis, transdermal

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: osteoarthritis of the hip, knee, or spine for 1 year or longer. taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. Exclusion Criteria: taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.

Sites / Locations

  • Parkway Medical Center
  • Edwards Lake Medical Center
  • Rheumatogogy Associates of N. Alabama,
  • Drug Research and Analysis Corp.
  • Meadowbrook Research
  • Research Solutions, LLC
  • Central Arkansas Research
  • Crest Clinical Research, Inc
  • NuLife Clinical Research, Inc.
  • Orange County Clinical Research
  • Private Practice
  • Andwell Research
  • Valerius Medical Group & Research Center Inc.
  • Anesthesiology and Pain Management
  • Scripps Clinic Ranchro Bernardo
  • Orrin M. Troum & Medical Associates
  • Diablo Clinical Research
  • Private Practice
  • Mountainview Clinical Research
  • Private Practice
  • Medical Research Associates
  • LifeSpan Clinical Research
  • Ocala Rheumatology Research Center
  • Sarasota Arthritis Center
  • University Neurology
  • Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
  • Wilker/Powers Center for Clinical Studies
  • Pinnacle Trials, Inc.
  • Clinical Investigative Services Med College of Georgia
  • America's Doctor (SMO)
  • Dolby Providers, Inc.
  • Professional Clinical Research
  • Private Practice
  • Lake Michigan Clinical Research and Consulting, Inc.
  • Research Center of the Ozarks, , MO
  • Comprehensive Clinical Research
  • Cherry Hill Orthopedic Surgeons
  • Private Practice
  • Univeristy of Medicine and Dentistry of New Jersey
  • Crescent Medical Assoc.
  • Private Practice
  • State University of NY at Stonybrook
  • Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
  • Albermarle Family Practice
  • New Hanover Medical Research
  • Odyssey Research Services
  • Midwest Regional Research
  • COR Clinical Research, LLC
  • Lyle, Austin Alexander PA
  • Rouge Valley Clinical Research
  • Southern Oregon Health & Wellness
  • Keystone Clinical Solutions, Inc.
  • Sidney Hillman Medical Center
  • Arcuri Clinical Research
  • The Arthritis & Osteoporosis Center
  • Alpha Clinical Research
  • Holston Medical Group
  • Integrity Clinical Research, LLC (SMO)
  • LifeTree Clinical Reseach
  • J. Lewis Research Foothill Family Clinic
  • J. Lewis Research Foothill Family Clinic South
  • Arthritis Clinic of No. Virginia
  • MedSource
  • Vantage Clinical Research Group
  • Arthritis Northwest
  • Clinical Trials Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BTDS 5

BTDS 20

Arm Description

Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear

Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear

Outcomes

Primary Outcome Measures

The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).

Secondary Outcome Measures

Full Information

First Posted
April 28, 2006
Last Updated
August 27, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00320801
Brief Title
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Official Title
A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to administrative reasons.
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Chronic pain, osteoarthritis, transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS 5
Arm Type
Active Comparator
Arm Description
Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
Arm Title
BTDS 20
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Primary Outcome Measure Information:
Title
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Description
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Time Frame
Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: osteoarthritis of the hip, knee, or spine for 1 year or longer. taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week. Exclusion Criteria: taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis. Other protocol-specific exclusion/inclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah O'Keefe, BSN
Organizational Affiliation
Purdue Pharma L.P., Stamford, CT
Official's Role
Study Chair
Facility Information:
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Edwards Lake Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Rheumatogogy Associates of N. Alabama,
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Drug Research and Analysis Corp.
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Meadowbrook Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Research Solutions, LLC
City
Searcy
State/Province
Arizona
ZIP/Postal Code
72143
Country
United States
Facility Name
Central Arkansas Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Crest Clinical Research, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
NuLife Clinical Research, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Orange County Clinical Research
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Private Practice
City
Laguna Hills
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Andwell Research
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Valerius Medical Group & Research Center Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90802
Country
United States
Facility Name
Anesthesiology and Pain Management
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Scripps Clinic Ranchro Bernardo
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Orrin M. Troum & Medical Associates
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Private Practice
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80005
Country
United States
Facility Name
Mountainview Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Private Practice
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Medical Research Associates
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
LifeSpan Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Sarasota Arthritis Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
University Neurology
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Wilker/Powers Center for Clinical Studies
City
St. Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Pinnacle Trials, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Clinical Investigative Services Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
America's Doctor (SMO)
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Dolby Providers, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70128
Country
United States
Facility Name
Professional Clinical Research
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
Facility Name
Private Practice
City
Oak Park
State/Province
Michigan
ZIP/Postal Code
48237
Country
United States
Facility Name
Lake Michigan Clinical Research and Consulting, Inc.
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Research Center of the Ozarks, , MO
City
Everton
State/Province
Missouri
ZIP/Postal Code
65646
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Cherry Hill Orthopedic Surgeons
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Private Practice
City
Medford
State/Province
New Jersey
ZIP/Postal Code
08055
Country
United States
Facility Name
Univeristy of Medicine and Dentistry of New Jersey
City
Stratford
State/Province
New Jersey
ZIP/Postal Code
08084
Country
United States
Facility Name
Crescent Medical Assoc.
City
Astoria
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Facility Name
Private Practice
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
State University of NY at Stonybrook
City
Stonybrook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Albermarle Family Practice
City
Elizabeth City
State/Province
North Carolina
ZIP/Postal Code
27909
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
Odyssey Research Services
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Midwest Regional Research
City
Bellbrook
State/Province
Ohio
ZIP/Postal Code
45305
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lyle, Austin Alexander PA
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Rouge Valley Clinical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Southern Oregon Health & Wellness
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Keystone Clinical Solutions, Inc.
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Sidney Hillman Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Arcuri Clinical Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19142
Country
United States
Facility Name
The Arthritis & Osteoporosis Center
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Alpha Clinical Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Integrity Clinical Research, LLC (SMO)
City
Milan
State/Province
Tennessee
ZIP/Postal Code
38358
Country
United States
Facility Name
LifeTree Clinical Reseach
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
J. Lewis Research Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Arthritis Clinic of No. Virginia
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
MedSource
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Vantage Clinical Research Group
City
Lacey
State/Province
Washington
ZIP/Postal Code
98516
Country
United States
Facility Name
Arthritis Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Clinical Trials Northwest
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information

Learn more about this trial

Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

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